Microbiologist
Job Requisition #: 12330
Date Posted: 02/02/2012
Category: Microbiology
Location: Westford - MA - USA
About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?
We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA:
Job Overview
Position Summary:
This position involves learning the application of microbiological concepts to the manufacturing process of a medical device and understanding process monitoring to maintain microbiological quality of the final device.
Essential Functions:
• Provides Facility Microbiological Support
o Record review of routine microbiological test results
o Routine release of manufactured product
o Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods.
o Handles routine out of specification test results.
o Begins understanding of data analysis of sterilization processes.
o Participate in audits of sterilization, test lab, and biological product vendors.
• Documentation
o Ensures correct documentation linkage flow for microbiologically related documents.
o Writes new or updates current microbiologically related documents.
• Maintains understanding of applicable standards and applies them to qualifications and test methods.
• Writes protocols and reports for qualifications for sterilization and microbiological test methods.
o Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation.
• Technical Training
o Provides training to laboratory technicians on new equipment or new test procedures.
o Provides training in the areas of sterilization validation and sterilization processes.
• Other Projects as Directed by Department Manager.
Qualifications:
• Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology.
• Two to three years in a medical device, medical, pharmaceutical, food industry, or related industry (FDA controlled).
• Two to three years in microbiology and/or sterilization
• Person in this position demonstrates professional skills
• Articulates technical concepts well
• Excellent written communication
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